QUALITY

Quality Assurance, Quality Control and Regulatory CMC Support

Our rigorous QA and QC protocols have been designed to ensure your products meet all standards for regulatory compliance and are safe for use by patients.

At Northway Biotech, we share your goal of delivering innovative therapeutics to patients in need, and we are collectively committed to advancing that goal through robust quality management systems, stringent quality controls and an innate understanding of the global regulatory landscape. Our depth of experience translates to the unwavering quality, safety and efficacy of your product across its full lifecycle.

Quality Assurance (QA)

As an organization, we are continuously improving our processes to remain at the forefront of current and upcoming regulations. Our QA department oversees all production and quality systems to ensure our clients’ products are manufactured according to cGMP requirements and are safe for patient administration. Our long track record of successful inspections by regulatory authorities and clients highlights the robustness of our QA program.

QA at Northway Biotech

Ensures cGMP compliance
Trains staff to promote company-wide adherence to QA protocols
Coordinates and conducts internal and external audits of Northway Biotech's quality management system
Organizes and enacts corrective and preventative actions with regard to quality management
Manages documentation, change control, deviations and complaints
Approves or rejects intermediates, drug substances and drug products according to QA standards

From the earliest stages of development, we are wholly focused on your commercial success...

Quality Control (QC)

Our QC department ensures all in process and finished biopharmaceutical products meet predefined criteria by employing a variety of advanced techniques to demonstrate both physical and chemical characteristics. The department also conducts environmental monitoring and process control to ensure cGMP compliance. Our QC staff is committed to excellence through quality by experience, biopharmaceutical industry expertise and continuous training.

QC at Northway Biotech

Ensures the quality of the company's products and services
Prepares specifications, SOPs, sampling, testing and documentation of all incoming starting materials, drug substance and drug product
Implements, qualifies and validates analytical methods (ICH) used for characterization and control of cell banks, raw materials, drug substances and drug products
Performs QC testing of cell banks, raw materials, drug substance and drug products
Manages reference standards, retention samples and analytical (assay) cell banks used for drug substance and drug product analysis
Manages real-time, accelerated and stressed stability programs
Prepares and executes environmental/critical systems monitoring programs
Performs process validation support testing

Regulatory Affairs

Our regulatory affairs experts compile and review all of the necessary data and documentation for regulatory CMC submissions to ensure products comply with applicable regulations.

Regulatory Affairs at Northway Biotech

Prepares required CMC documentation for INDs / IMPDs and BLAs / MAAs, as well as new product registrations and maintenance of existing registrations
Confirms compliance of products with strict quality and safety requirements
Reviews the quality, content and format of regulatory submissions
Ensures submissions are complete, consistent and adhere to all necessary standards